Neck PainNCT05712239
Effect of Lumber Core Stability Exercises on Chronic Non-specific Neck Pain
A study testing Advices, Cervical and Scapular Stabilization Exercises and Lumber Core Stability Program in people with Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Chronic non-specific neck pain patients will be enrolled in 3 groups in this study including passive, active control and experimental groups to determine the effect of adding lumbar core stability exercises to patient's advices and cervical and scapular stabilization exercises. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Advices, Cervical and Scapular Stabilization Exercises and Lumber Core Stability Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with persistent cervical pain for more than 12 weeks without specific diagnosis (chronic non-specific neck pain).
- BMI less than 30 kg/m2.
- Pain intensity on VAS should be more than 3.
- Patient will be able and motivated in completing the study.
- Psychologically \& mentally stable.
Who cannot join
- Red Flag's symptoms including a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower or upper extremity neurological deficit.
- Pregnant women.
- Recent or old fractures at spine or upper limbs.
- Congenital, or acquired postural deformity.
- No previous neck or spinal or shoulder surgery.
- No current pathologies (e.g. Disc lesion, nerve root compression, canal stenosis, spinal tumor, spinal infection, systemic inflammatory diseases, …).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Giza
Hend W Mostafa, MSc, 00201004225661, hendwageh.95@gmail.com
About this study
Official title: Effect of Adding Lumbar Core Stability Exercises to Cervical and Scapular Stabilization Exercises and Advices on Chronic Non- Specific Neck Pain
Chronic non-specific neck pain patients will be enrolled in 3 groups in this study including passive, active control and experimental groups to determine the effect of adding lumbar core stability exercises to patient's advices and cervical and scapular stabilization exercises. For the last two groups, the sessions will be applied 3 times per week for 4 weeks. All the outcomes will be measured after patient's enrollment and at the end of 4 weeks to determine the difference between groups.
- Conditions
- Neck Pain
- Being tested
- Advices, Cervical and Scapular Stabilization Exercises, Lumber Core Stability Program
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvicesOther
The advices will include patient's reassurance and description of possible causes of neck pain such as poor working ergonomics, common bad postures especially while using electronic devices for long periods and not adjustable sleeping pillows. Also, patient will be educated how to modify these different causes and asked to apply gentle neck range of motion exercises
Cervical and Scapular Stabilization ExercisesOther
Deep neck flexor training will be performed in neurodevelopment stages (supine at first week using pressure biofeedback unit , prone at second week, quadrupedal at third week, bipedal at fourth week).
Scapular stabilization exercises will include modified prone cobra, trapezius muscle exercise progression (3 stages), wall press and extension of the thoracic spine using foam roller. The modified prone cobra and the first stage of trapezius muscle exercise progression will be applied during the first two weeks. The second and third stages of trapezius muscle exercise will be applied during the last two weeks of our rehabilitation program. All exercises will be applied for 10 repetitions with 6-10 sec hold for 3 sets with 20 sec rest between each set. While wall press and thoracic extension exercises will be applied throughout the 4 weeks for 3 sets of 10 repetitions with 20 sec rest between each set.
Lumber Core Stability ProgramOther
The program will be performed in three stages: activation, dynamic stabilization, and advanced core strengthening stages. Each stage will be applied for 4 sessions.
The activation stage will be based on the learning to activate transversus abdominis muscle from crock lying position using pressure biofeedback unit. In the dynamic stabilization stage, the patient will be instructed to slowly raise both arms in the scapular plan then return to the sides while maintaining the transversus abdominis muscle activation. Also, the patient will apply bridging exercise in this stage. The advanced core strengthening stage will include prone plank and side plank (right and left sides). All the exercises will be applied for 10 repetitions with 6-10 sec hold for 3 sets. The rest of 20 sec will be taken between each set.
| Study group | Role | What they receive |
|---|---|---|
| Advices Group | Other | Patients in this group will take only advices about their postures and activities of daily living Receives: Other: Advices |
| Cervical and scapular stabilization Group | Active comparator | Patients in this group will take advices and stability exercises for neck and scapula Receives: Other: Advices; Other: Cervical and Scapular Stabilization Exercises |
| Neck, scapular and lumber stabilization Group | Experimental | Patients in this group will take advices, and stability exercises for neck, scapula and lumber spine Receives: Other: Advices; Other: Cervical and Scapular Stabilization Exercises; Other: Lumber Core Stability Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain intensity
Pain intensity will be assessed by using Visual analogue scale (VAS). It is horizontal line with 10 cm length, with Zero marked at one end representing no pain and 10 marked at the other end representing worst imaginable pain.
Measured: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change in functional disability
Functional disability will be assessed using Arabic version of neck disability index. The patients will be asked to make a mark in each section which most closely described their problem. Each section consists of six potential responses for each item ranging from no disability (0) to total disability (5). Thus, The NDI score ranges between 0-100, with higher scores indicating greater perceived disability. The score of less than 4 indicates no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, and scores greater than 35 complete disabilities.
Measured: This outcome will be assessed at the first day and after 4 weeks following end of treatment
Secondary outcomes (6)
change in Craniovertebral angle degree (CVA)
To measure CVA, the patient will be captured from the left side after putting landmarks on seventh cervical vertebra (c7) and tragus of the ear. The photograph will be taken and analyzed with kinovea software by drawing a horizontal line passing through C7 and line connecting between the tragus of the ear and C7 and measuring the angle between these lines. As the value of CVA decreases, the degree of FHP increases
Measured: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of of deep neck flexor muscles (DNF) activation
DNF activation will be assessed by Craniocervical flexion test using Pressure biofeedback unit
Measured: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of deep neck flexor (DNF) endurance
DNF endurance will be assessed by Neck flexor endurance test
Measured: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of trunk flexor muscle endurance
Trunk flexor muscle endurance will be assessed by Trunk flexion test (McGill's test)
Measured: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of trunk extensor muscle endurance
Trunk extensor muscle endurance will be assessed by Trunk extension test (Sorenson Test)
Measured: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of lateral trunk muscle endurance
Lateral trunk muscle endurance will be assessed Side plank test for left and right sides
Measured: This outcome will be assessed at the first day and after 4 weeks following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start5 Feb 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Wageh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712239
- Sponsor's protocol ID
- P.T.REC/012/003950
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Lumbar Core Stability Exercises to Cervical and Scapular Stabilization Exercises and Advices on Chronic Non- Specific Neck Pain
- ClinicalTrials.gov ID
- NCT05712239
- Acronym / sponsor ID
- P.T.REC/012/003950
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic non-specific neck pain patients will be enrolled in 3 groups in this study including passive, active control and experimental groups to determine the effect of adding lumbar core stability exercises to patient's advices and cervical and scapular stabilization exercises. For the last two groups, the sessions will be applied 3 times per week for 4 weeks. All the outcomes will be measured after patient's enrollment and at the end of 4 weeks to determine the difference between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Advices Group | Other | Other: AdvicesPatients in this group will take only advices about their postures and activities of daily living |
| Cervical and scapular stabilization Group | Active comparator | Other: Advices, Other: Cervical and Scapular Stabilization ExercisesPatients in this group will take advices and stability exercises for neck and scapula |
| Neck, scapular and lumber stabilization Group | Experimental | Other: Advices, Other: Cervical and Scapular Stabilization Exercises, Other: Lumber Core Stability ProgramPatients in this group will take advices, and stability exercises for neck, scapula and lumber spine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with persistent cervical pain for more than 12 weeks without specific diagnosis (chronic non-specific neck pain).
- BMI less than 30 kg/m2.
- Pain intensity on VAS should be more than 3.
- Patient will be able and motivated in completing the study.
- Psychologically \& mentally stable.
Key exclusion criteria (6 listed)
- Red Flag's symptoms including a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower or upper extremity neurological deficit.
- Pregnant women.
- Recent or old fractures at spine or upper limbs.
- Congenital, or acquired postural deformity.
- No previous neck or spinal or shoulder surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdvicesThe advices will include patient's reassurance and description of possible causes of neck pain such as poor working ergonomics, common bad postures especially while using electronic devices for long periods and not adjustable sleeping pillows. Also, patient will be educated how to modify these different causes and asked to apply gentle neck range of motion exercises | Other | Advices Group, Cervical and scapular stabilization Group, Neck, scapular and lumber stabilization Group |
| Cervical and Scapular Stabilization ExercisesDeep neck flexor training will be performed in neurodevelopment stages (supine at first week using pressure biofeedback unit , prone at second week, quadrupedal at third week, bipedal at fourth week). Scapular stabilization exercises will include modified prone cobra, trapezius muscle exercise progression (3 stages), wall press and extension of the thoracic spine using foam roller. The modified prone cobra and the first stage of trapezius muscle exercise progression will be applied during the first two weeks. The second and third stages of trapezius muscle exercise will be applied during the last two weeks of our rehabilitation program. All exercises will be applied for 10 repetitions with 6-10 sec hold for 3 sets with 20 sec rest between each set. While wall press and thoracic extension exercises will be applied throughout the 4 weeks for 3 sets of 10 repetitions with 20 sec rest between each set. | Other | Cervical and scapular stabilization Group, Neck, scapular and lumber stabilization Group |
| Lumber Core Stability ProgramThe program will be performed in three stages: activation, dynamic stabilization, and advanced core strengthening stages. Each stage will be applied for 4 sessions. The activation stage will be based on the learning to activate transversus abdominis muscle from crock lying position using pressure biofeedback unit. In the dynamic stabilization stage, the patient will be instructed to slowly raise both arms in the scapular plan then return to the sides while maintaining the transversus abdominis muscle activation. Also, the patient will apply bridging exercise in this stage. The advanced core strengthening stage will include prone plank and side plank (right and left sides). All the exercises will be applied for 10 repetitions with 6-10 sec hold for 3 sets. The rest of 20 sec will be taken between each set. | Other | Neck, scapular and lumber stabilization Group |
Primary outcome
change in pain intensity
Time frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
Pain intensity will be assessed by using Visual analogue scale (VAS). It is horizontal line with 10 cm length, with Zero marked at one end representing no pain and 10 marked at the other end representing worst imaginable pain.
change in functional disability
Time frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
Functional disability will be assessed using Arabic version of neck disability index. The patients will be asked to make a mark in each section which most closely described their problem. Each section consists of six potential responses for each item ranging from no disability (0) to total disability (5). Thus, The NDI score ranges between 0-100, with higher scores indicating greater perceived disability. The score of less than 4 indicates no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, and scores greater than 35 complete disabilities.
6 secondary outcomes
change in Craniovertebral angle degree (CVA)
Time frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of of deep neck flexor muscles (DNF) activation
Time frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of deep neck flexor (DNF) endurance
Time frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of trunk flexor muscle endurance
Time frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of trunk extensor muscle endurance
Time frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
change of lateral trunk muscle endurance
Time frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advices, Cervical and Scapular Stabilization Exercises and Lumber Core Stability Program in people with Neck Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend W Mostafa, MSc (00201004225661, hendwageh.95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain intensity (time frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.